[Phase II study of (2''R)-4'-O-tetrahydropyranyldoxorubicin (THP) in patients with advanced gastrointestinal cancer--a report of the Tohoku THP Study Group].

A phase II study of THP was performed in patients with advanced gastrointestinal cancer. The dose schedule was 25 to 40 mg/m2 i.v./cycle repeated every 3 to 4 weeks. One partial (PR) and one minor response (MR) were achieved in 16 evaluable patients with stomach cancer. A case of PR had previously been shown to be resistant to doxorubicin and a case of MR resistant to aclarubicin, respectively. No objective responses were observed in 19 evaluable patients with other tumor sites in the gastrointestinal tract. Forty-eight patients were evaluable for toxic effects. Leukopenia (less than 4 X 10(3)/mm3) occurred in 54% of the patients and was dose-limiting. Thrombocytopenia (less than 10 X 10(4)/mm3) was less frequently observed (13%) than leukopenia. However, no cumulative marrow suppression was observed in repeated courses of the therapy. Non-hematologic toxic effects consisted of gastrointestinal disturbances (23%), hair loss (10%), general malaise (8%), fever (6%), ECG changes (4%) and hepatic dysfunction (2%). Further trials with a high dose schedule (40 mg/m2, q 3-4 weeks) in good-risk patients are necessary to validate the antitumor activity of THP against advanced gastrointestinal cancer.